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HyperForm
Micro Therapeutics, Inc. · Model 104-4370 · UDI-DI 00763000294175
MJN
Prescription
2
510(k) clearances
2,330
Adverse events (101 deaths)
21
Recalls
62
Facilities
Description
BALLOON SYSTEM 104-4370 V20 HYPERFORM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-12 | W. L. Gore & Associates Inc. | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to infl |
| 2020-10-29 | Prytime Medical Devices, Inc. | There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient. |
| 2020-03-31 | Spectranetics Corporation | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not |
| 2019-07-24 | LeMaitre Vascular, Inc. | incorrect device size being listed on the impacted device packaging |
| 2018-10-01 | LeMaitre Vascular, Inc. | Pouches from this lot are not sealed compromising the sterility |
| 2017-08-07 | Spectranetics Corporation | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. |
| 2016-10-31 | Spectranetics Corporation | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to poten |
| 2016-10-06 | AccessClosure, Inc., A Cardinal Health Company | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absen |
| 2015-11-25 | RenovoRx, Inc. | Incorrect version of Instructions for Use were shipped to two US customers. |
| 2013-11-04 | Stryker Neurovascular | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. |
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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.