Needleless Sling NL-01Recalls & reported problems

Desarrollo E Investigacion Medica Aragonesa Sl · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08437007606058), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Erosion1
Pelvic Pain1
Urinary Incontinence1

Recent adverse event reports

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

InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A NEEDLELESS SLING DEVICE IMPLANTED IN 2008. ON TWO OCCASIONS SHORTLY AFTER THE SURGERY, MINOR RESECTIONS OF THE SLING MATERIAL WERE PERFORMED DUE TO EROSION. IN (B)(6) 2025, THE PATIENT REPORTED EROSION. THE CURRENT HEALTH OF THE PATIENT IS IN GOOD HEALTH, WITH NORMAL AGE-RELATED PROBLEMS. THE PATIENT HAS PAIN AND URINARY INCONTINENCE.
Patient problems: Erosion; Pelvic Pain; Urinary Incontinence
MAUDE report 24283719 ↗

Device details

UDI-DI	`08437007606058`
Brand	Needleless Sling
Model	NL-01
Company	Desarrollo E Investigacion Medica Aragonesa Sl
Product code	PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Female stress urinary incontinence surgical mesh-sling, synthetic polymer

A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.

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