Home › Zoll Circulation, Inc. › 10.7F PACKAGED ACCUTROL CATHETER
10.7F PACKAGED ACCUTROL CATHETER
Zoll Circulation, Inc. · Model NA · UDI-DI 00849111075404
NCX
Prescription
1
510(k) clearances
4,407
Adverse events (44 deaths)
35
Recalls
4
Facilities
Description
The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
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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.