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NA CAT00241Recalls & reported problems

Stryker Corporation · PORTAL ENTRY KIT · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613252632863), received between Jun 22, 2018 and Aug 17, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Sep 13, 2023Open, Classified

    Expired product distributed

    Z-0287-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Break4
  • Expiration Date Error2

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient2
  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • Insufficient Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 17, 2023Expiration Date Error; Expiration Date Error

    IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17568282 ↗
  • MalfunctionAug 17, 2023Expiration Date Error; Expiration Date Error

    IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17568180 ↗
  • MalfunctionJun 21, 2022Break; Break

    IT WAS REPORTED THAT THE GUIDEWIRE BROKE AND THE PROCEDURE WAS CONVERTED TO OPEN TO RETRIEVE THE BROKEN GUIDEWIRE.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 14754591 ↗
  • MalfunctionJan 11, 2022Break

    IT WAS REPORTED THAT THE GUIDEWIRE BROKE. THE PIECE WAS RETRIEVED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13229406 ↗
  • MalfunctionDec 5, 2019Break; Break

    IT WAS REPORTED THAT A PIECE BROKE OFF OF THE DEVICE DURING THE PROCEDURE THAT LED TO A 45 MINUTE DELAY. THE PIECE WAS RETRIEVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9417148 ↗
  • MalfunctionJun 22, 2018Break

    IT WAS REPORTED THAT PRODUCT BROKE DURING USE. ALL BROKEN PIECES WERE RETRIEVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7629841 ↗

Other KIT, SURGICAL INSTRUMENT, DISPOSABLE devices

All KIT, SURGICAL INSTRUMENT, DISPOSABLE devices →

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