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Delta® 27554-5Recalls & reported problems

Medtronic Ps Medical, Inc. · VALVE 27554-5 DELTA SM EXTRACTED PL 1.5 · Class 2 · Implant

All models of Delta (31)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169483149), received between Dec 21, 2019 and Dec 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

31 other recalls cover devices cleared under the same FDA submission (K951258); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Device Appears to Trigger Rejection1

Patient problems

  • Hypersensitivity/Allergic reaction1
  • Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    IT WAS REPORTED THE PATIENT HAD A REACTION TO THEIR IMPLANT. IT WAS STATED THE PATIENT HAD BEEN EXPERIENCING IRRITATION WITH THEIR TUBING/VALVE. THEY WERE TESTED FOR ALLERGIES, AND XYLENE WAS FOUND AS AN ALLERGEN FOR THEM.

    Patient problems: Hypersensitivity/Allergic reaction; Irritation

    MAUDE report 9508146 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951258. One submission often covers many models, so check the product and lot details in each record.

  • Z-1115-2021 · Jan 11, 2021 · Open, Classified
    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 -
  • Z-1117-2021 · Jan 11, 2021 · Open, Classified
    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY
  • Z-1132-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plas
  • Z-1131-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plas
  • Z-1146-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1130-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plas
  • Z-1133-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plas
  • Z-1136-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1134-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek pla
  • Z-1147-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1150-2009 · Feb 12, 2009 · Terminated
    Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar po
  • Z-1128-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plast
  • Z-1142-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The
  • Z-1124-2009 · Feb 12, 2009 · Terminated
    Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plas
  • Z-1137-2009 · Feb 12, 2009 · Terminated
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The

…and 16 more.

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Sources and updates

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