| Date Initiated by Firm |
November 08, 2019 |
| Date Posted |
December 19, 2019 |
| Recall Status1 |
Terminated 3 on March 24, 2021 |
| Recall Number |
Z-0717-2020 |
| Recall Event ID |
84363 |
| PMA Number |
P980037 |
| Product Classification |
Catheter, coronary, atherectomy - Product Code MCX
|
| Product |
AngioJet Ultra Consoles-Thrombectomy System
UPN:
105650-001D
105650-001H
105650-001R
105650-001Z
105650-002R
105650-004H
105650-004R
105650-007R
105650-009R
105650-024H
105650-024Z
105650-025
105650-025H
105650-025R
105650-026R
Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console. |
| Code Information |
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08714729890607¿ U2919 105650-001R 08714729890607¿ U2928 105650-001R 08714729890607¿ U2937 105650-001R 08714729890607¿ U2956 105650-001R 08714729890607¿ U2991 105650-001R 08714729890607¿ U2995 105650-001R 08714729890607¿ U3004 105650-001R 08714729890607¿ U3026 105650-001R 08714729890607¿ U3032 105650-001R 08714729890607¿ U3060 105650-001R 08714729890607¿ U3092 105650-001R 08714729890607¿ U3096 105650-001R 08714729890607¿ U3135 105650-001R 08714729890607¿ U3138 105650-001R 08714729890607¿ U3140 105650-001R 08714729890607¿ U3143 105650-001R 08714729890607¿ U3197 105650-001R 08714729890607¿ U3227 105650-001R 08714729890607¿ U3229 105650-001R 08714729890607¿ U3231 105650-001R 08714729890607¿ U3232 105650-001R 08714729890607¿ U3235 105650-001R 08714729890607¿ U3241 105650-001R 08714729890607¿ U3284 105650-001R 08714729890607¿ U3286 105650-001R 08714729890607¿ U3332 105650-001R 08714729890607¿ U3358 105650-001R 08714729890607¿ U3365 105650-001R 08714729890607¿ U3379 105650-001R 08714729890607¿ U3380 105650-001R 08714729890607¿ U3388 105650-001R 08714729890607¿ U3409 105650-001R 08714729890607¿ U3415 105650-001R 08714729890607¿ U3433 105650-001R 08714729890607¿ U3454 105650-001R 08714729890607¿ U3461 105650-001R 08714729890607¿ U3464 105650-001R 08714729890607¿ U3466 105650-001R 08714729890607¿ U3495 105650-001R 08714729890607¿ U3504 105650-001R 08714729890607¿ U3516 105650-001R 08714729890607¿ U3555 105650-001R 08714729890607¿ U3572 105650-001R 08714729890607¿ U3597 105650-001R 08714729890607¿ U3609 105650-001R 08714729890607¿ U3614 105650-001R 08714729890607¿ U3716 105650-001R 08714729890607¿ U3718 105650-001R 08714729890607¿ U3754 105650-001R 08714729890607¿ U3769 105650-001R 08714729890607¿ U3807 105650-001R 08714729890607¿ U3904 105650-001R 08714729890607¿ U3932 105650-001R 08714729890607¿ U3986 105650-001R 08714729890607¿ U4058 105650-001R 08714729890607¿ U4110 105650-001R 08714729890607¿ U4144 105650-001R 08714729890607¿ U4154 105650-001R 08714729890607¿ U4237 105650-001R 08714729890607¿ U4299 105650-001R 08714729890607¿ U4322 105650-001R 08714729890607¿ U4351 105650-001R 08714729890607¿ U4363 105650-001R 08714729890607¿ U4369 105650-001R 08714729890607¿ U4371 105650-001R 08714729890607¿ U4389 105650-001R 08714729890607¿ U4426 105650-001R 08714729890607¿ U4428 105650-001R 08714729890607¿ U4437 105650-001R 08714729890607¿ U4442 105650-001R 08714729890607¿ U4444 105650-001R 08714729890607¿ U4467 105650-001R 08714729890607¿ U4471 105650-001R 08714729890607¿ U4520 105650-001R 08714729890607¿ U5024 105650-001R 08714729890607¿ U5025 105650-001R 08714729890607¿ U5034 105650-001R 08714729890607¿ U5050 105650-001R 08714729890607¿ U5093 105650-001R 08714729890607¿ U5094 105650-001R 08714729890607¿ U5126 105650-001R 08714729890607¿ U5185 105650-001R 08714729890607¿ U5189 105650-001R 08714729890607¿ U5198 105650-001R 08714729890607¿ U6001 105650-001R 08714729890607¿ U6056 105650-001R 08714729890607¿ U6061 105650-001R 08714729890607¿ U6071 105650-001R 08714729890607¿ U6072 105650-001R 08714729890607¿ U6077 105650-001R 08714729890607¿ U6080 105650-001R 08714729890607¿ U6084 105650-001R 08714729890607¿ U6088 105650-001R 08714729890607¿ U6089 105650-001R 08714729890607¿ U6096 105650-001R 08714729890607¿ U6098 105650-001R 08714729890607¿ U6100 105650-001R 08714729890607¿ U6104 105650-001R 08714729890607¿ U6111 105650-001R 08714729890607¿ U6115 105650-001R 08714729890607¿ U6120 105650-001R 08714729890607¿ U6129 105650-001R 08714729890607¿ U6130 105650-001R 08714729890607¿ U6131 105650-001R 08714729890607¿ U6151 105650-001R 08714729890607¿ U6154 105650-001R 08714729890607¿ U6164 105650-001R 08714729890607¿ U6172 105650-001R 08714729890607¿ U6178 105650-001R 08714729890607¿ U6192 105650-001R 08714729890607¿ U6301 105650-001R 08714729890607¿ U6310 105650-001R 08714729890607¿ U6326 105650-001R 08714729890607¿ U6327 105650-001R 08714729890607¿ U6332 105650-001R 08714729890607¿ U6345 105650-001R 08714729890607¿ U6354 105650-001R 08714729890607¿ U6357 105650-001R 08714729890607¿ U6358 105650-001R 08714729890607¿ U6364 105650-001R 08714729890607¿ U6368 105650-001R 08714729890607¿ U6369 105650-001R 08714729890607¿ U6370 105650-001R 08714729890607¿ U6372 105650-001R 08714729890607¿ U6379 105650-001R 08714729890607¿ U6428 105650-001R 08714729890607¿ U6451 105650-001R 08714729890607¿ U6452 105650-001R 08714729890607¿ U6457 105650-001R 08714729890607¿ U6458 105650-001R 08714729890607¿ U6460 105650-001R 08714729890607¿ U6468 105650-001R 08714729890607¿ U6476 105650-001R 08714729890607¿ U6494 105650-001R 08714729890607¿ U6506 105650-001R 08714729890607¿ U6518 105650-001R 08714729890607¿ U6565 105650-001R 08714729890607¿ U6669 105650-001Z 08714729892199¿ U5029 105650-001Z 08714729892199¿ U5096 105650-002R 08714729890638 U2704 105650-004H 08714729890683¿ U3788 105650-004H 08714729890683¿ U5073 105650-004R 08714729890690 U3192 105650-007R 08714729890782 U3179 105650-007R 08714729890782 U3191 105650-007R 08714729890782 U3396 105650-007R 08714729890782 U4108 105650-007R 08714729890782 U4224 105650-009R 08714729890843 U3371 105650-024H 08714729891284 U4112 105650-024Z 08714729892656¿ U8808 105650-025 08714729891307¿ U8047 105650-025H 08714729891314 U8511 105650-025R 08714729891321¿ U3278 105650-025R 08714729891321¿ U3858 105650-025R 08714729891321¿ U8041 105650-025R 08714729891321¿ U8049 105650-025R 08714729891321¿ U8050 105650-025R 08714729891321¿ U8052 105650-025R 08714729891321¿ U8054 105650-025R 08714729891321¿ U8059 105650-025R 08714729891321¿ U8060 105650-025R 08714729891321¿ U8062 105650-025R 08714729891321¿ U8073 105650-025R 08714729891321¿ U8074 105650-025R 08714729891321¿ U8075 105650-025R 08714729891321¿ U8080 105650-025R 08714729891321¿ U8081 105650-025R 08714729891321¿ U8089 105650-025R 08714729891321¿ U8148 105650-025R 08714729891321¿ U8153 105650-025R 08714729891321¿ U8195 105650-025R 08714729891321¿ U8197 105650-025R 08714729891321¿ U8214 105650-025R 08714729891321¿ U8560 105650-025R 08714729891321¿ U8564 105650-025R 08714729891321¿ U8594 105650-025R 08714729891321¿ U8631 105650-025R 08714729891321¿ U8802 105650-025R 08714729891321¿ U8803 105650-025R 08714729891321¿ U8804 105650-025R 08714729891321¿ U8835 105650-025R 08714729891321¿ U8854 105650-025R 08714729891321¿ U8872 105650-025R 08714729891321¿ U8879 105650-025R 08714729891321¿ U8883 105650-025R 08714729891321¿ U8885 105650-025R 08714729891321¿ U8907 105650-025R 08714729891321¿ U8919 105650-025R 08714729891321¿ U8942 105650-025R 08714729891321¿ U8980 105650-025R 08714729891321¿ U8985 105650-025R 08714729891321¿ U8993 105650-025R 08714729891321¿ U9047 105650-025R 08714729891321¿ U9048 105650-025R 08714729891321¿ U9078 105650-026R 08714729891352¿ U8260 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
|
| For Additional Information Contact |
Nicole Pshon
763-494-1133
|
Manufacturer Reason
for Recall |
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
|
FDA Determined
Cause 2 |
Reprocessing Controls |
| Action |
Boston Scientific Customer issued notification letters dated 11/08/19 via overnight mail delivery. Letter states reason for recall, health risk and action to take: AngioJet Repaired Consoles located at affected accounts will remain in the field. An AngioJet DFU will be provided to accounts to correct the previous DFU omission with the distribution of the Repaired Console.
Your local Sales Representative can answer any questions that you may have regarding this correction. Please pass this notice to any healthcare professional from your organization who needs to be aware and to any organization where these devices have been transferred (if appropriate). |
| Quantity in Commerce |
169 units ((OUS: 44 US: 125) |
| Distribution |
Worldwide distribution - US Nationwide distribution and country of Canada. |
| Total Product Life Cycle |
TPLC Device Report
|
|
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| PMA Database |
PMAs with Product Code = MCX and Original Applicant = Boston Scientific Corp.
|
