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Class 1 Device Recall Imager II 5F Angiographic Catheter |
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| Date Initiated by Firm |
February 11, 2020 |
| Date Posted |
March 25, 2020 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1555-2020 |
| Recall Event ID |
84886 |
| 510(K)Number |
K121694
|
| Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
|
| Product |
Imager II 5F Angiographic Catheters, 5 units per package. |
| Code Information |
All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M001314130 11 Material Number (UPN) Outer Package M001314141, Material Number (UPN) Inner Package M001314140 12 Material Number (UPN) Outer Package M001314151, Material Number (UPN) Inner Package M001314150 13 Material Number (UPN) Outer Package M001314161, Material Number (UPN) Inner Package M001314160 14 Material Number (UPN) Outer Package M001314171, Material Number (UPN) Inner Package M001314170 15 Material Number (UPN) Outer Package M001314181, Material Number (UPN) Inner Package M001314180 16 Material Number (UPN) Outer Package M001314191, Material Number (UPN) Inner Package M001314190 17 Material Number (UPN) Outer Package M001314211, Material Number (UPN) Inner Package M001314210 18 Material Number (UPN) Outer Package M001314221, Material Number (UPN) Inner Package M001314220 19 Material Number (UPN) Outer Package M001314231, Material Number (UPN) Inner Package M001314230 20 Material Number (UPN) Outer Package M001314241, Material Number (UPN) Inner Package M001314240 21 Material Number (UPN) Outer Package M001314251, Material Number (UPN) Inner Package M001314250 22 Material Number (UPN) Outer Package M001314261, Material Number (UPN) Inner Package M001314260 23 Material Number (UPN) Outer Package M001314271, Material Number (UPN) Inner Package M001314270 24 Material Number (UPN) Outer Package M001314301, Material Number (UPN) Inner Package M001314300 25 Material Number (UPN) Outer Package M001314311, Material Number (UPN) Inner Package M001314310 26 Material Number (UPN) Outer Package M001314321, Material Number (UPN) Inner Package M001314320 27 Material Number (UPN) Outer Package M001314331, Material Number (UPN) Inner Package M001314330 28 Material Number (UPN) Outer Package M001314341, Material Number (UPN) Inner Package M001314340 29 Material Number (UPN) Outer Package M001314351, Material Number (UPN) Inner Package M001314350 30 Material Number (UPN) Outer Package M001314361, Material Number (UPN) Inner Package M001314360 31 Material Number (UPN) Outer Package M001314371, Material Number (UPN) Inner Package M001314370 32 Material Number (UPN) Outer Package M001314391, Material Number (UPN) Inner Package M001314390 33 Material Number (UPN) Outer Package M001314401, Material Number (UPN) Inner Package M001314400 34 Material Number (UPN) Outer Package M001314411, Material Number (UPN) Inner Package M001314410 35 Material Number (UPN) Outer Package M001314421, Material Number (UPN) Inner Package M001314420 36 Material Number (UPN) Outer Package M001314431, Material Number (UPN) Inner Package M001314430 37 Material Number (UPN) Outer Package M001314441, Material Number (UPN) Inner Package M001314440 38 Material Number (UPN) Outer Package M001314451, Material Number (UPN) Inner Package M001314450 39 Material Number (UPN) Outer Package M001314461, Material Number (UPN) Inner Package M001314460 40 Material Number (UPN) Outer Package M001314471, Material Number (UPN) Inner Package M001314470 41 Material Number (UPN) Outer Package M001314481, Material Number (UPN) Inner Package M001314480 42 Material Number (UPN) Outer Package M001314501, Material Number (UPN) Inner Package M001314500 43 Material Number (UPN) Outer Package M001314521, Material Number (UPN) Inner Package M001314520 44 Material Number (UPN) Outer Package M001314531, Material Number (UPN) Inner Package M001314530 45 Material Number (UPN) Outer Package M001314541, Material Number (UPN) Inner Package M001314540 46 Material Number (UPN) Outer Package M001314551, Material Number (UPN) Inner Package M001314550 47 Material Number (UPN) Outer Package M001314561, Material Number (UPN) Inner Package M001314560 48 Material Number (UPN) Outer Package M001314571, Material Number (UPN) Inner Package M001314570 49 Material Number (UPN) Outer Package M001314581, Material Number (UPN) Inner Package M001314580 50 Material Number (UPN) Outer Package M001314591, Material Number (UPN) Inner Package M001314590 51 Material Number (UPN) Outer Package M001314621, Material Number (UPN) Inner Package M001314620 52 Material Number (UPN) Outer Package M001314631, Material Number (UPN) Inner Package M001314630 53 Material Number (UPN) Outer Package M001314641, Material Number (UPN) Inner Package M001314640 54 Material Number (UPN) Outer Package M001314651, Material Number (UPN) Inner Package M001314650 55 Material Number (UPN) Outer Package M001314661, Material Number (UPN) Inner Package M001314660 56 Material Number (UPN) Outer Package M001314671, Material Number (UPN) Inner Package M001314670 57 Material Number (UPN) Outer Package M001314681, Material Number (UPN) Inner Package M001314680 58 Material Number (UPN) Outer Package M001314691, Material Number (UPN) Inner Package M001314690 59 Material Number (UPN) Outer Package M001314701, Material Number (UPN) Inner Package M001314700 60 Material Number (UPN) Outer Package M001314711, Material Number (UPN) Inner Package M001314710 61 Material Number (UPN) Outer Package M001314751, Material Number (UPN) Inner Package M001314750 62 Material Number (UPN) Outer Package M001314761, Material Number (UPN) Inner Package M001314760 63 Material Number (UPN) Outer Package M001314771, Material Number (UPN) Inner Package M001314770 64 Material Number (UPN) Outer Package M001314781, Material Number (UPN) Inner Package M001314780 65 Material Number (UPN) Outer Package M001314791, Material Number (UPN) Inner Package M001314790 66 Material Number (UPN) Outer Package M001314801, Material Number (UPN) Inner Package M001314800 67 Material Number (UPN) Outer Package M001314811, Material Number (UPN) Inner Package M001314810 68 Material Number (UPN) Outer Package M001314821, Material Number (UPN) Inner Package M001314820 69 Material Number (UPN) Outer Package M001314831, Material Number (UPN) Inner Package M001314830 70 Material Number (UPN) Outer Package M001314841, Material Number (UPN) Inner Package M001314840 71 Material Number (UPN) Outer Package M001314851, Material Number (UPN) Inner Package M001314850 72 Material Number (UPN) Outer Package M001314861, Material Number (UPN) Inner Package M001314860 73 Material Number (UPN) Outer Package M001314871, Material Number (UPN) Inner Package M001314870 74 Material Number (UPN) Outer Package M001314881, Material Number (UPN) Inner Package M001314880 75 Material Number (UPN) Outer Package M001314891, Material Number (UPN) Inner Package M001314890 76 Material Number (UPN) Outer Package M001314901, Material Number (UPN) Inner Package M001314900 77 Material Number (UPN) Outer Package M001314911, Material Number (UPN) Inner Package M001314910 78 Material Number (UPN) Outer Package M001315031, Material Number (UPN) Inner Package M001315030 79 Material Number (UPN) Outer Package M001315051, Material Number (UPN) Inner Package M001315050 80 Material Number (UPN) Outer Package M001315061, Material Number (UPN) Inner Package M001315060 81 Material Number (UPN) Outer Package M001315071, Material Number (UPN) Inner Package M001315070 82 Material Number (UPN) Outer Package M001315081, Material Number (UPN) Inner Package M001315080 83 Material Number (UPN) Outer Package M001315131, Material Number (UPN) Inner Package M001315130 84 Material Number (UPN) Outer Package M001315141, Material Number (UPN) Inner Package M001315140 85 Material Number (UPN) Outer Package M001315151, Material Number (UPN) Inner Package M001315150 86 Material Number (UPN) Outer Package M001315191, Material Number (UPN) Inner Package M001315190 87 Material Number (UPN) Outer Package M001315211, Material Number (UPN) Inner Package M001315210 88 Material Number (UPN) Outer Package M001315231, Material Number (UPN) Inner Package M001315230 89 Material Number (UPN) Outer Package M001315281, Material Number (UPN) Inner Package M001315280 90 Material Number (UPN) Outer Package M001315291, Material Number (UPN) Inner Package M001315290 91 Material Number (UPN) Outer Package M001315301, Material Number (UPN) Inner Package M001315300 92 Material Number (UPN) Outer Package M001315311, Material Number (UPN) Inner Package M001315310 93 Material Number (UPN) Outer Package M001315321, Material Number (UPN) Inner Package M001315320 94 Material Number (UPN) Outer Package M001315331, Material Number (UPN) Inner Package M001315330 **** UPDATE: The firm expanded this recall to include ALL lots/batches of the 5F curved tip shapes of the Imager II Angiographic Catheters on 08/05/2020. This update is posted in RES on 10/05/2020. |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
|
| For Additional Information Contact |
Nicole Pshon
763-494-1133
|
Manufacturer Reason
for Recall |
Potential for tip detachment of Imager II 5F Angiographic Catheters
|
FDA Determined
Cause 2 |
Environmental control |
| Action |
Boston Scientific notified customers on about 02/11/2020 via "Urgent Medical Device Removal" letter. Customers were informed that Boston Scientific has noticed an increase in the rate of tip detachment complaints involving the recalled devices.
Instructions included to examine inventory and quarantine affected products, complete and return the Verification Form, return all affected devices to Boston Scientific, and notify customers if affected devices were further distributed.
An expansion letter was dated 08/06/2020 to include all batches/lots of the BSC Imager II Angiographic Catheter - 5 French Curved Tip Shapes. |
| Quantity in Commerce |
1068827 Single Units |
| Distribution |
Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa. |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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