DELTAPAQ DFS100720-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007890), received between Oct 10, 2018 and Aug 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 reports).

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

Recent adverse event reports

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

• MalfunctionAug 14, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PELVIC VARICOSE VEIN EMBOLIZATION PROCEDURE, THE 7MM X 20CM DELTAPAQ 10 STRETCH RESISTANT COIL (DFS10072020 / S12180) WAS DAMAGED AND DID NOT PROGRESS IN THE CONCOMITANT 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155FX / 30036042). THE DEVICE WAS REMOVED. IT WAS REPORTED THAT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN SLIGHTLY STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS (B)(6) 2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411401 ↗
• MalfunctionOct 10, 2018Stretched; Separation Failure; Material Twisted/Bent; Stretched; Separation Failure; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE 7MM X 20CM DELTAPAQ SR PLAT (DFS10072020/S11333) THERMO-MECHANICAL COIL FAILED TO DETACH. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952053 ↗