Restella R20253-1018GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09421905067058), received between Sep 10, 2019 and Sep 10, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 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.

• InjurySep 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A UNILATERAL (RIGHT) MASTECTOMY, AFTER WHICH A 500CC ALLERGAN EXPANDER WAS IMPLANTED. BEFORE IMPLANTATION, THE POCKET WAS IRRIGATED WITH CHLORPACTIN AND THE SKINFLAP TREATED WITH BETADYNE. TWO RESTELLA 10X18.5CM RESORBABLE CONTOURS WERE SEWN TOGETHER WITH 3-0 MONOCRYL AND ATTACHED TO THE EXPANDER TABS. THE EXPANDER TABS AND SOME OF THE RESTELLA WERE ATTACHED TO THE CHEST WALL. A BLAKE DRAIN WAS PLACED MEDIALLY AND ALONG THE IMF AND THE SKIN FLAP CLOSED. THE INCISION WAS COVERED WITH GAUZE AND TEGRADERM. ON (B)(6) 2019 THE EXPANDER AND RESTELLA WERE REMOVED DUE TO DEHISCENCE/EXPOSURE. THERE WAS NOTED SKIN NECROSIS AND INFECTION.

  Patient problems: Necrosis; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 8984595 ↗
• InjurySep 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT A UNILATERAL (RIGHT) MASTECTOMY, AFTER WHICH A 500CC EXPANDER WAS IMPLANTED. BEFORE IMPLANTATION, THE POCKET WAS IRRIGATED WITH CHLORPACTIN AND THE SKINFLAP TREATED WITH BETADYNE. TWO RESTELLA DEVICES WERE SEWN TOGETHER WITH 3-0 MONOCRYL, COVERING THE EXPANDER AND ATTACHED TO ITS TABS. THE EXPANDER TABS WERE ATTACHED TO THE CHEST WALL. A BLAKE DRAIN WAS PLACED MEDIALLY AND ALONG THE IMF AND THE SKIN FLAP CLOSED. THE INCISION WAS COVERED WITH GAUZE AND WOUND DRESSING. ON (B)(6) 2019, ABOUT A WEEK AFTER SURGERY, THE SKIN FLAP HAD DEVELOPED NECROSIS AND BECAME INFECTED. AS A RESULT THE EXPANDER AND ITS RESTELLA COVER WERE REMOVED.

  Patient problems: Necrosis; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 8983935 ↗