PROXIMATE XR30GRecalls & reported problems
Ethicon Endo-Surgery, LLC · Proximate Linear Stapler Reloads · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036013440), received between Jan 14, 2019 and Mar 3, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Open or Close1
- Failure to Form Staple1
Patient problems
- Failure to Anastomose1
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498232 ↗InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THREE DAYS POST OP TO A LAPAROSCOPIC APPENDECTOMY THE PATIENT WAS RE-OPERATED ON FOR A STAPLE LINE LEAK. CLIPS AND BIOSURGERY WERE USED TO REPAIR THE LEAK. THE PATIENT IS DOING FINE.
Patient problems: Failure to Anastomose; Hematoma
MAUDE report 16887793 ↗MalfunctionJan 14, 2019Difficult to Open or Close
IT WAS REPORTED THAT WHILE THE LOBECTOMY SURGERY, XR30G DID NOT CLOSE THE BRONCHUS TISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8245242 ↗
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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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