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Rigid Pneumatic Probe

BOSTON SCIENTIFIC CORPORATION · Model M0068407310 · UDI-DI 08714729516620

FFK Prescription
10
510(k) clearances
438
Adverse events (9 deaths)
21
Recalls
34
Facilities

Description

Rigid Pneumatic Probe

Recalls

DateFirmReason
2022-04-13Northgate Technologies, Inc.Product labeled incorrectly.
2021-10-25Northgate Technologies, Inc.The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2020-03-10Northgate Technologies, Inc.As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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Data 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.