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iSnare
US Endoscopy · Model 00711089 · UDI-DI 00816765010945
10
510(k) clearances
570
Adverse events
42
Recalls
98
Facilities
Description
The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2024-10-04 | Hobbs Medical, Inc. | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inne |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
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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.