| Date Initiated by Firm | January 13, 2026 |
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| Date Posted | February 26, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1473-2026 |
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| Recall Event ID |
98354 |
| Product Classification |
Stabilizer, heart - Product Code MWS
|
| Product | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 |
|---|
| Code Information |
UDI-DI: 00763000543693;
Lot Number: 0232837110,
Additional lots as of 5/22/26: 0231547054
0231591827
0231758880
0231758898
0231758932
0231792414
0231792421
0231912903
0232670901
0232709219
0232709254
0232744928
0232784925
0232784989
0232805458 |
| FEI Number |
1000116158
|
Recalling Firm/
Manufacturer |
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park
MN
55428-1088
|
| For Additional Information Contact | Medtronic Customer Service
800-854-3570 |
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Manufacturer Reason
for Recall | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated January 2026 was hand delivered to customers.
Actions:
Medtronic requests that you take the following actions:
" Review your inventory for listed lot number.
" If you have inventory from the listed lot number immediately quarantine and return it to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary.
" Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have the affected product in your possession.
" Please maintain a copy of this communication in your records.
If you have any questions regarding this communication, please contact your Medtronic Field Representative.
An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/12/26 was sent to customers.
Customer Actions:
Medtronic requests that you take the following actions:
" Review your inventory for lot numbers listed in Attachment A.
" If you have unused inventory from the listed lot numbers, immediately quarantine and return the products to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary.
" Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have the affected product in your possession.
" Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
" Please maintain a copy of this communication in your records.
If you |
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| Quantity in Commerce | 939 units |
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| Distribution | US Nationwide. Global Distribution. |
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| 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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