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MobiCath™ D140011Recalls & reported problems

Greatbatch Ltd · MobiCath BiDirectional Guiding Sheath, Large Curve · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846835012371), received between Jun 10, 2016 and Jun 10, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Markings/Labelling Problem2

Patient problems

  • Not Applicable2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 10, 2016Device Markings/Labelling Problem; Device Markings/Labelling Problem

    THE OUTER BAG ON THIS PRODUCT IS LABELED AS LARGE BUT WHEN OPENED THERE IS ANOTHER BAG WITH THE MARKING SMALL ON IT. THE ISSUE WAS NOTICED AT THE PRODUCT DISTRIBUTOR'S DISTRIBUTION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: Not Applicable

    MAUDE report 5718336 ↗
  • MalfunctionJun 10, 2016Device Markings/Labelling Problem; Device Markings/Labelling Problem

    THE DESCRIPTION ON THE PRODUCT PACKAGING IS NOT CORRECT. IT SHOWS SMALL CURVE BUT IT SHOULD BE LARGE CURVE, THE ITEM NUMBER AND LOT ARE CORRECT. THE ISSUE WAS NOTICED AT THE PRODUCT DISTRIBUTOR'S DISTRIBUTION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: Not Applicable

    MAUDE report 5718326 ↗

Other Introducer, Catheter devices

All Introducer, Catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.