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Class 2 Device Recall Impella |
 |
| Date Initiated by Firm |
December 27, 2023 |
| Date Posted |
February 12, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1074-2024 |
| Recall Event ID |
93746 |
| Product Classification |
Temporary non-roller type left heart support blood pump - Product Code OZD
|
| Product |
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system.
(1) Product Code 005042 - Impella 2.5
(2) Product Code 005062 - Impella 5.0
(3) Product Code 005082- Impella LD
(4) Product Code 004334 - Impella RP
(5) Product Code 0046-0035 - Impella RP with SmartAssist
(6) Product Code 1000323 - RP Flex with SmartAssist
(7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist
(8) Product Code 0048-0032 - Impella CP
(9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist
--
***Added 2/20/24***
(10) 4413 and 004413 - Impella 2.5 Set
(11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU
(12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU
(13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada
(14) 1000115 - Impella CP Pump set, APAC
(15) 1000211 - Impella 5.5 Smart Assist Set, JP
(16) 1000302 - Impella CP with SmartAssist APAC
(17) 1000361 - Impella 5.5 Set AU
(18) 1000402 - Impella CP Smart Assist Set
(19) 0046-0011 - Impella RP Pump Set, EU
(20) 0046-0026 - Impella 5.0 Pump Set ROW
(21) 0046-0037 - Impella 5.0 Pump Set APAC
(22) 0046-0039 - Impella RP Set APAC
(23) 004690-AU - Impella 5.0 Pump Set AU
(24) 0048-0002 - Impella CP Pump Set, EU
(25) 0048-0002-BR - Impella CP Pump Set BR
(26) 0048-0004 - Impella CP Pump Set, Canada
(27) 0048-0014 - Impella Smart Assist Set, EU
(28) 0048-0024-JP - Impella CP Smart Assist Set, JP
(29) 0048-0044 - Impella CP Smart Assist Set, Canada
(30) 0048-0047- Impella CP Smart Assist Set APAC
(31) 005048-JP - Impella 2.5 Pump Set, Japan
(32) 005066-JP - Impella 5.0 Pump Set, Japan
(33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU
(34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA |
| Code Information |
UDI-DI
(1) 00813502011081
(2) 00813502011180
(3) 00813502011227
(4) 00813502011029
(5) 00813502011869
(6) 00813502012811
(7) 00813502011531 and 00813502012828
(8) 00813502011388
(9) 00813502012279 and 00813502011876
All products are affected by IFU Update
***Added 2/20/24***
(10) 813502010947
(11) 4260113630136
(12) 4260113630174
(13) 813502011197
(14) 813502010473
(15) 813502012453
(16) 813502012767
(17) 813502012927
(18) 813502012873
(19) 4260113630273
(20) 813502011821
(21) 813502011937
(22) 813502011951
(23) N/A
(24) 4260113630242
(25) 813502011777
(26) 813502011265
(27) 4260113630280
(28) 813502011609
(29) 813502012200
(30) 813502011944
(31) 813502010046
(32) 813502010053
(33) 813502011630
(34) 813502010466
|
Recalling Firm/
Manufacturer |
Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
|
| For Additional Information Contact |
978-646-1400
|
Manufacturer Reason
for Recall |
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
|
FDA Determined
Cause 2 |
Labeling Change Control |
| Action |
On December 27, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE CORRECTION letters.
Customers were informed of the IFU update, which included a New Warning:
"To reduce the possibility of fibers being drawn into the Impella, customers should avoid exposing the inlet and cannula section of the Impella Heart Pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers."
The IFU udpate also includes updates to Potential Adverse Events and Warnings to add potential of cardiac or vascular injury. That part of the recall is classified and tracked under RES 93749.
Customers should review the IFU updates and send their response form to the recalling firm. Please forward the recall notice to all impacted parties at your facility as well as any facilities to whom subject product has been forwarded.
Post a copy of the notice in a visible area for awareness.
Customers with questions may contact recallcoordinators@abiomed.com. |
| Quantity in Commerce |
92515 |
| Distribution |
Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI. |
| 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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