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MozecTM Rx PTCA Balloon Dilatation Catheter
MERIL LIFE SCIENCES PRIVATE LIMITED · Model MOZ30033 · UDI-DI 18904224907932
LOX
Prescription
10
510(k) clearances
43,512
Adverse events (583 deaths)
121
Recalls
77
Facilities
Description
MozecTM Rx PTCA Balloon Dilatation Catheter, 3.00 mm x 33 mm, Rapid Exchange
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-24 | Medtronic Inc | Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| 2020-01-29 | Abbott Vascular | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.