superDimension AKI00131-01Recalls & reported problems

Covidien LP · Patient Sensor Patch · Class 2

Data updated Oct 13, 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 10884521807976), received between Mar 19, 2025 and Mar 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Packaging Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMar 19, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THERE WAS A LABELING ISSUE WITH THE PATIENT SENSOR PATCH PACKAGE. THE CUSTOMER CHECKED THE DELIVERED SENSOR PATCH PACKAGE AND NOTICED A SHORT USE BY DATE OF 2025-08-21, DESPITE THE MANUFACTURING DATE BEING 2025-01-23, INDICATING A POSSIBLE LABELING ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21649164 ↗

Device details

UDI-DI	`10884521807976`
Brand	superDimension
Model	AKI00131-01
Company	Covidien LP
Product code	JAK · System, x-ray, tomography, computed
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 21, 2025

Device type (GMDN): Multi-purpose surgical skin adhesive tape

A long thin band of synthetic material coated on one or both sides with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or a combination of materials. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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