Dover 3570Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521016743), received between Aug 15, 2019 and Apr 27, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2015, A CATHETER CHANGE WENT POORLY; THE CATHETER WAS STUCK AND THE NURSE HAD TO USE FORCE TO REMOVE IT. THE CUSTOMER STATED HE WAS SWEATING AND FELT BLADDER TENSION FOR 3 DAYS AFTERWARD, OFF AND ON. THE CATHETER WAS INSERTED ON (B)(6) 2015. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER DETAILS.

  Patient problems: Discomfort

  MAUDE report 11735197 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2021. HE BEGAN TAKING OXYBUTYNIN 5MG IN THE MORNING AND EVENING BUT IS HAVING REGULAR EPISODES OF AUTONOMIC DYSREFLEXIA (AD), 3 OR 4 PER HOUR, BUT THEY WERE NOT AS SEVERE ON (B)(6) 2021. HOWEVER, THE NIGHT OF (B)(6) 2021 HIS BLOOD PRESSURE WAS 212/106 WITH A PULSE OF 43 DURING A FIVE MINUTE AD EPISODE BEFORE GOING TO BED, I.E. ONE DAY OF OXYBUTYNIN WAS NOT ENOUGH TO HELP. THE CUSTOMER FURTHER STATED THAT THIS CATHETER EXPIRED IN 2018 WHICH HE WAS AWARE OF PRIOR TO INSERTION. HE CONFIRMED THAT THE CATHETER IS DRAINING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 7-APR-2021 STATED THAT THE CATHETER IS STILL IN USE AND HE HAS HAD NO FURTHER ISSUES, (B)(6) 2021 WAS THE LAST DAY HE TOOK OXYBUTYNIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bradycardia; High Blood Pressure/ Hypertension

  MAUDE report 11691146 ↗
• InjuryApr 13, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT A CATHETER INSERTED ON (B)(6) 2021 SEEMED TO BE DRAINING POORLY CAUSING PERIODIC HYPERREFLEXIA (SWEATING, PULSING HEADACHE). THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 26-MAR-2021 STATED THAT HE DID NOT TAKE ANY MEDICATION TO TREAT THE ISSUES WHILE USING THE CATHETER. ON (B)(6) 2021 HIS BLOOD PRESSURE WAS 191/99 DURING A SPIKE (AD = AUTONOMIC DYSREFLEXIA) WITH A PULSE OF 42, BUT WAS NORMAL TEN MINUTES LATER (106/73 PULSE 72). ADDITIONAL INFORMATION RECEIVED ON 30-MAR-2021 STATED THAT THE CATHETER WAS INSERTED BY A HEALTH PROFESSIONAL AND WAS NOT TESTED PRIOR TO USE BECAUSE IT NEEDED TO REMAIN STERILE. THIS CATHETER DRAINED AFTER BEING REMOVED. HE STATED THAT THE CATHETER WAS EITHER DRAINING INTERMITTENTLY SINCE IT DRAINS NOW, OR THERE WAS A PROBLEM WITH HIS BLADDER THAT HAS SINCE SUBSIDED.

  Patient problems: Headache; High Blood Pressure/ Hypertension

  MAUDE report 11661124 ↗
• InjuryApr 13, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2021, AND SEEMED TO BE DRAINING POORLY, CAUSING HYPERREFLEXIA (HIGH BLOOD PRESSURE, POTENTIALLY VERY DANGEROUS) SO IT HAD TO BE CHANGED 3.5 DAYS LATER ON (B)(6) 2021. ADDITIONAL INFORMATION STATED THAT HE DID NOT TAKE ANY MEDICATION TO TREAT THE ISSUES WHILE USING THE CATHETER. THE CATHETER WAS INSERTED BY A HEALTH PROFESSIONAL AND WAS NOT TESTED PRIOR TO USE BECAUSE IT NEEDED TO REMAIN STERILE. THIS CATHETER DRAINED AFTER BEING REMOVED AND HE STATED THAT IT WAS EITHER DRAINING INTERMITTENTLY SINCE IT DRAINS NOW OR THERE WAS A PROBLEM WITH HIS BLADDER THAT HAS SINCE SUBSIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 11661020 ↗
• MalfunctionAug 15, 2019No Flow; No Flow

  THE PATIENT REPORTS THAT THE SUPRAPUBIC FOLEY CATHETER WAS INSERTED ON (B)(6) 2019 AND STOPPED DRAINING ON THE EVENING OF (B)(6) 2019 AT THE PATIENT'S HOME. THE PATIENT STATED THAT THE CATHETER WAS NOT CLOGGED, IT JUST STOPPED DRAINING COMPLETELY AFTER FOUR DAYS. THE PATIENT STATED HE HAS BEEN A C5 QUADRIPLEGIC FOR 34 YEARS, AND USING THE MEDTRONIC COVIDIEN BRAND FOLEY CATHETER FOR AT LEAST TEN YEARS AND CHANGES THEM EVERY 4 WEEKS. WHEN USING THE CATHETER HE DOES NOT REALIZE THERE IS A PROBLEM UNTIL HIS BLOOD PRESSURE (BP) GOES UP (180/95 TO 210/110) AND HE STARTS SWEATING DUE TO AUTONOMIC DYSREFLEXIA. HE WAS ABLE TO HAVE SOMEONE DRAIN THE BALLOON BUT ONLY AN INSIGNIFICANT AMOUNT OF URINE WAS ABLE TO BE DRAINED. HIS BP STAYED HIGH AND SOMEONE APPLIED NITRO PASTE LOWERING THE BP SOMEWHAT. AFTER 1.5 HOURS, A NURSE ARRIVED AND CHANGED THE CATHETER, ABOUT 24 OZ OF URINE DRAINED, AND THE CRISIS ENDED.

  Patient problems: High Blood Pressure/ Hypertension; Sweating

  MAUDE report 8898912 ↗