Boston Scientific DGP-PM2-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15060441917628), received between Jan 21, 2024 and Apr 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2024Use of Device Problem; Use of Device Problem

  CUSTOMER COMPLAINT CC 1676 WAS RECEIVED BY NISSHA ON THE (B)(6) 2024 AND REFERRED TO AN ADVERSE EVENT OCCURRING IN THE UNITED STATES WHERE A BURN WAS REPORTED TO PATIENTS LEFT THIGH. FURTHER INFORMATION RECEIVED ON (B)(6) 2024 - INITIALLY SILVADENE CREME WAS APPLIED AND GIVEN TO THE PATIENT. HE THEN WENT TO A PCP WHO PLACED HIM ON ANTIBIOTICS, MORE SILVADENE CREME, AND BACTROBAN OINTMENT. THE PATIENT HAS NOW BEEN REFERRED TO A WOUND CARE SPECIALIST FOR HIS BURNS. SINCE THERE WAS MEDICAL INTERVENTION, NMT HAS CONCISDERED THIS A REPORTABLE EVENT.

  Patient problems: Burn(s)

  MAUDE report 19084692 ↗
• InjuryJan 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BURNING SENSATION REPORTED AT THE SITE OF PAD DURING PROCEDURE. HOSPITAL REPORTED NO DEFECTS OBSERVED ON THE PAD. PAD REPLACED WITH ANOTHER FROM THE SAME LOT WITH NO ISSUES. PATIENT TREATED WITH BANDAID AND ANTIBIOTIC

  Patient problems: Burn(s)

  MAUDE report 18549174 ↗