Maquet Inc Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Brand
Maquet Inc
Lot Codes / Batch Numbers
Lot numbers: 162119, 162572, 163299, 164050, 165934, 167444, 167446, 171658, 176841, 178282, 179626, 180352, 180822, 184419, 185618, 186149, 187100, 188865.
Products Sold
Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865.
Maquet Inc is recalling Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter). due to Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approv. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026