Z-1061-05

Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter)

Name: Z-1061-05 Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter)
Creator: Maquet Inc
Published: 2005-05-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2005-05-20 / Terminated / root cause: manufacturing process

FDA source

Maquet Inc began a recall of Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter) on 2005-05-20. The reason FDA records is "Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1061-05
Status: Terminated
Initiated: 2005-05-20
Posted: 2005-08-03
Terminated: 2006-10-03
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.

Product code DWF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)