ENDOPATH LONG45ARecalls & reported problems

Ethicon Endo-Surgery, LLC · ETS-Flex45 Endoscopic Articulating Long Linear Cutter, No Reload · Class 2

All models of ENDOPATH (37)

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 20705036002427), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Defective Component1
Product Quality Problem1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionJun 28, 2018Product Quality Problem; Defective Component
IT WAS REPORTED THAT PRODUCT WAS RECEIVED AT (B)(6) COMPLAINT HANDLING UNIT. SHIPPING DOC: LONG45A; PLEASE RETURN DEFECTIVE PRODUCT; POOR QUALITY. NO OTHER DETAILS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7648052 ↗

Device details

UDI-DI	`20705036002427`
Brand	ENDOPATH
Model	LONG45A
Company	Ethicon Endo-Surgery, LLC
Product code	GDW · STAPLE, IMPLANTABLE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Endoscopic manual linear cutting stapler, single-use

A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

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All STAPLE, IMPLANTABLE devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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