FDA Medical Device Recalls (openFDA)
Maquet Inc: Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
- Recall number
- Z-1061-05
- Recalling firm
- Maquet Inc
- Product
- Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
- Status
- Terminated
- Initiated
- 2005-05-20
- Posted
- 2005-08-03
- Terminated
- 2006-10-03
- Reason
- Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.
- Root cause
- Other
- Action
- Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary.
- Quantity
- 890 units
- Distribution
- Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.
- Lot, serial or model codes
- Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3008355164
- Firm city
- East Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28