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FlowPort CAT00776Recalls & reported problems

Stryker Corporation · FLOWPORT II CANNULA WITH OBTUR · Class 1

Adverse event reports
8
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613252632887), received between Apr 1, 2019 and Jan 27, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture5
  • Break2
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Foreign Body In Patient2
  • Insufficient Information2
  • No Information1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 27, 2026Fracture

    IT WAS REPORTED THAT THE TIP OF FLOWPORT BROKE OFF IN JOINT OF MALE PATIENT. IT WAS RETRIEVED BEFORE CLOSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24195857 ↗
  • MalfunctionSep 29, 2025Fracture; Fracture

    IT WAS REPORTED THAT THE PLASTIC TIP OF CANNULA BROKE INTO THE PATIENT. THIS WAS RETRIEVED BY THE SURGEON HOWEVER THIS PROCEDURE WAS PROLONGED BY 15 MINUTES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23175671 ↗
  • InjuryJan 30, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING THE PROCESS OF ENTERING THE HIP JOINT THE STRYKER BLUNT PLASTIC CANNULA WAS PINCHED BETWEEN THE LATERAL RIM OF THE ACETABULUM END FEMORAL HEAD AND APPROXIMATELY 1.6CM PLASTIC PIECE BROKE OFF. X-RAYS REVEALED THAT IT WAS PINCHED BETWEEN THE LATERAL ACETABULUM AND FEMORAL HEAD. THE FINAL X RAYS REVEALED A WELL REDUCED HIP JOINT WITH RETAINED PLASTIC PIECE UNCHANGED FROM INTRAOPERATIVE X-RAYS.

    Patient problems: Foreign Body In Patient; Insufficient Information

    MAUDE report 21277214 ↗
  • InjuryNov 11, 2024Fracture; Fracture

    IT WAS REPORTED THAT THE TIP OF THE CANNULA BROKE OFF IN THE PATIENT JOINT SPACE. IT WAS ABLE TO BE LOCATED BUT COULD NOT BE REMOVED. A SECOND SURGERY WILL BE REQUIRED.

    Patient problems: Foreign Body In Patient

    MAUDE report 20655776 ↗
  • MalfunctionApr 3, 2024Fracture; Fracture

    IT WAS REPORTED THAT THE TIP BREAKING DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19038634 ↗
  • MalfunctionFeb 17, 2022Break

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13549292 ↗
  • MalfunctionFeb 10, 2022Break

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

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

    MAUDE report 13507540 ↗
  • InjuryApr 1, 2019Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.

    Patient problems: No Information

    MAUDE report 8471349 ↗

Other ACCESSORIES,ARTHROSCOPIC devices

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