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Applier, hemostatic clip
PETERS SURGICAL · Model PO420-E · UDI-DI 03661522039748
4
510(k) clearances
362
Adverse events (1 deaths)
14
Recalls
69
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-19 | LeMaitre Vascular, Inc. | The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distr |
| 2014-01-23 | Atricure Inc | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. |
| 2010-09-22 | Lemaitre Vascular, Inc. | Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while th |
| 2010-09-22 | Lemaitre Vascular, Inc. | Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and Large sizes incorrectly identified the size of the clip as XL, while th |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
| 2004-08-18 | Weck | The jaws may break during clip loading or clip application. |
| 2003-10-24 | Weck | Hole in the sterile unit blister pack that could compromise sterility. |
| 2003-10-24 | Weck | Hole in the sterile unit blister pack that could compromise sterility. |
| 2003-10-24 | Weck | Hole in the sterile unit blister pack that could compromise sterility. |
| 2003-10-24 | Weck | Hole in the sterile unit blister pack that could compromise sterility. |
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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.