RAD® 1883519HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20885074080653), received between Aug 3, 2018 and Dec 12, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Vibration; Connection Problem; Vibration; Connection Problem

  IT WAS REPORTED THAT PRIOR TO USE, BLADE WAS UNABLE TO ATTACH PROPERLY AND WOBBLING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, OTHER BLADE WHEN CONNECTED WITH THE SAME HANDPIECE DID NOT WOBBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787361 ↗
• MalfunctionDec 11, 2025Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE BLADE WAS NOT DAMAGED BUT THE INNER TUBE WAS HIDDEN AND THERE WAS NO LOSS OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776623 ↗
• MalfunctionOct 8, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING FESS PROCEDURE, BLADE WAS USED IN SURGERY AND THE OUTER SHEATH WAS UNSTABLE AND SLIDING UP AND DOWN DURING THE PROCEDURE. MOVED ON TO A SECOND ONE AND THE OUT SHEATH WAS UNSTABLE, THE BLADE WAS UNSTABLE BECAUSE THE OUTER SHEATH WAS NOT SEALED TO THE HUB. THE THIRD SHAVER THEY PICKED WORKED AS EXPECTED. PROCEDURE EXTENDED BY 1 HOUR. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393678 ↗
• MalfunctionApr 8, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY THE DEVICE HAD VIBRATION WHICH WAS TRANSMITTED MORE THAN USUAL. M4 HANDPIECE WAS USED AND WAS VIBRATING. THE NUMBER OF ROTATIONS WAS 3,000. PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO HEALTH DAMAGE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057339 ↗
• MalfunctionFeb 15, 2022Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT INTRA OP DURING FESS PROCEDURE, THE TIP OF THE DEVICE WAS WOBBLING BACK AND FORTH. THERE WAS NO PATIENT IMPACT. THERE WAS NO INTERVENTION REQUIRED AND THERE WAS NO DELAY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13533539 ↗
• MalfunctionDec 23, 2020Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT ON AN ESS (ENDOSCOPIC SINUS SURGERY), THE SHAFT WAS SUSPECTED TO BE OUT OF ALIGNMENT, AND IT WAS NOT STABLE IMMEDIATELY AFTER UNPACKING. THE SHAFT SHIFTED WHEN THE COLLET WAS TURNED. A STRUCTURE IN WHICH THE OPEN WINDOW PART AT THE TIP USUALLY ROTATES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT. THERE WAS ALSO AN ANOMALY WITH THE SAME LOT PRODUCT LAST TIME. ON FOLLOW-UP, IT WAS STATED THAT AFTER ATTACHING THE BLADE TO THE HANDPIECE, THE SHAFT WOBBLED AND THOUGHT THAT IT MIGHT HAVE BEEN USED TO THE PATIENT WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11063767 ↗
• MalfunctionNov 18, 2020Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE METAL PART AT THE TIP (SILVER) AND A LITTLE BIT OF THE RESIN PART AT THE ROOT (WHITE) OF THE BLADE CAME OFF DURING THE ENDOSCOPIC SINUS SURGERY (ESS) PROCEDURE. THERE WERE NO FRAGMENTS THAT FELL INTO THE PATIENT. THERE WERE NO ADDITIONAL PROCEDURES OR UNINTENDED EQUIPMENT REQUIRED TO RETRIEVE THE FRAGMENT. THERE WAS NO DELAY WITH THE PROCEDURE AS A BACK-UP DEVICE WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860402 ↗
• MalfunctionMar 17, 2020Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT A DEVICE WAS BROKEN AND FAULTY OUT OF THE PACKET DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9841244 ↗
• MalfunctionDec 3, 2019Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE WAS BROKEN/DAMAGED ON NORMAL USE DURING THE ENDOSCOPIC SINUS SURGERY. THERE WERE NO BROKEN PIECES REMAIN INSIDE THE PATIENT'S BODY. THE PRODUCT WAS USED FOR THE FIRST TIME AND THE PROCEDURE WAS COMPLETED WITH A BACK UP PRODUCT. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS NO DELAY WITH THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400358 ↗
• MalfunctionSep 16, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEVICE WAS ALREADY BROKEN WHEN THE PACKAGE WAS OPENED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070166 ↗
• MalfunctionJun 25, 2019Vibration; Connection Problem; Vibration; Connection Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING A ROUTINE SINUS SURGERY PROCEDURE, THE INNER PORTION OF THE BLADE HAS BECOME LOOSE AND SPINS ON ITS OWN WITHOUT TURNING THE BLADE. THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730531 ↗
• MalfunctionJun 5, 2019Mechanical Problem; Mechanical Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT DURING THE PROCEDURE, THE BLADE STARTED TO SHAKE AND THE SURGEON REALIZED THAT THE ROTATE TIP STOPPED FUNCTIONING CORRECTLY, IT WAS UNABLE TO REMOVE THE TISSUE. THE INNER AND OUTER BLADE WERE STUCK TOGETHER AND THE CUTTING CHAMBER WAS NOT OPEN. IT WAS NOTED THAT THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED AS A RESULT OF THIS EVENT. THERE WAS A 15-MINUTE DELAY WITH THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671483 ↗
• MalfunctionMay 16, 2019Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS NOT FUNCTIONING AS EXPECTED DURING THE PROCEDURE. UPON INSPECTION, THE HCP NOTICED THAT THE INNER CANNULA WAS DETACHED FROM THE OUTER CANNULA. IT WAS NOTED THAT THERE WAS NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE AND THE CASE WAS COMPLETED WITH A BACK-UP DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618208 ↗
• MalfunctionFeb 22, 2019Material Separation; Material Separation

  THE HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE INNER PIECE OF THE BLADE WAS DETACHED DURING THE PROCEDURE WHICH WAS NOT SUPPOSED TO HAPPEN. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361726 ↗
• MalfunctionJan 30, 2019Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE BROKE SHORTLY AFTER USE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE DEVICE DID NOT BREAK INTO PIECES. THERE WAS A DELAY OF LESS THAN AN HOUR. THE BLADE WAS SWITCHED OUT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288324 ↗
• MalfunctionAug 3, 2018Break

  THE CUSTOMER REPORTED THAT THE RAD BLADE WAS BROKEN; NO SPECIFIC DETAILS WERE GIVEN AND HAVE BEEN REQUESTED. THERE WAS NO PATIENT IMPACT OR INJURY ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7746191 ↗