ROTAPRORecalls & reported problems across all models
Boston Scientific Corporation · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,187
- Deaths reported
- 39
- Injuries reported
- 215
- Recalls
- 1
We found 14 models of ROTAPRO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,187 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2018 and Sep 29, 2026 — classified as 39 deaths, 215 injuries, 933 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (480 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ROTAPRO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 8, 2021Terminated
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Z-0381-2022 · Root cause: Employee error · Recall details · FDA record ↗
Most reported ROTAPRO problems
Device problems
- Entrapment of Device480
- Output Problem297
- Detachment of Device or Device Component163
- Intermittent Loss of Power148
- Adverse Event Without Identified Device or Use Problem118
- Difficult to Remove77
- Nonstandard Device77
- Noise, Audible65
Patient problems
- No Clinical Signs, Symptoms or Conditions926
- No Consequences Or Impact To Patient120
- Perforation28
- Perforation of Vessels27
- Vascular Dissection26
- Foreign Body In Patient21
- Low Blood Pressure/ Hypotension17
- Cardiac Tamponade15
ROTAPRO models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROTAPRO™ H749393001250CATHETER, CORONARY, ATHERECTOMY22 deaths573 reports
- ROTAPRO™ H749394671500CATHETER, CORONARY, ATHERECTOMY7 deaths205 reports
- ROTAPRO™ H749393001500CATHETER, CORONARY, ATHERECTOMY2 deaths142 reports
- ROTAPRO™ H74939309010CATHETER, CORONARY, ATHERECTOMY1 recall1 death41 reports
- ROTAPRO™ H749394671250CATHETER, CORONARY, ATHERECTOMY3 deaths77 reports
- ROTAPRO™ H749394671750CATHETER, CORONARY, ATHERECTOMY1 death59 reports
- ROTAPRO™ H749393001750CATHETER, CORONARY, ATHERECTOMY3 deaths42 reports
- ROTAPRO™ H749394672000CATHETER, CORONARY, ATHERECTOMY23 reports
- ROTAPRO™ H749393002000CATHETER, CORONARY, ATHERECTOMY9 reports
- ROTAPRO™ H7493930901R0CATHETER, CORONARY, ATHERECTOMY5 reports
- ROTAPRO™ H749394672250CATHETER, CORONARY, ATHERECTOMY5 reports
- ROTAPRO™ H749393002150CATHETER, CORONARY, ATHERECTOMY3 reports
- ROTAPRO™ H749394672150CATHETER, CORONARY, ATHERECTOMY2 reports
- ROTAPRO™ H749393002250CATHETER, CORONARY, ATHERECTOMY1 report
Recent ROTAPRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Entrapment of Device; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938888 ↗InjurySep 26, 2026Entrapment of Device; Material Separation; Output Problem; Intermittent Loss of Power
Patient problems: Vascular Dissection
MAUDE report 50909428 ↗InjurySep 25, 2026Entrapment of Device; Output Problem; Intermittent Loss of Power
Patient problems: Bradycardia; Ischemia; Non specific EKG/ECG Changes; Vascular Dissection
MAUDE report 50903205 ↗MalfunctionSep 24, 2026Mechanical Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891313 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848310 ↗MalfunctionSep 18, 2026Fluid/Blood Leak; Nonstandard Device
Reportable based on device analysis completed on 28Aug2026.It was reported that a fluid leak occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery. A 1.50mm RotaPro was selected for use. During the procedure while outside the patient, when performing air removal on the advancer, near the tube where the Rota cocktail flows, Rota solution was leaking out. The procedure was completed with another of the same device and no patient complications were reported. However, device analysis revealed the sheath was torn at 20.6cm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820255 ↗MalfunctionSep 15, 2026Entrapment of Device; Intermittent Loss of Power
It was reported that the burr got stuck in the lesion.The target lesion was located in the severely tortuous and severely calcified left anterior descending artery. A 1.50mm RotaPro was selected for use. During the procedure, it was noted that the burr became stuck due to challenging and complex anatomy. The device was continuously stalling. The device was removed and another of the same device was used to complete the procedure successfully. There were no complications reported and the patient is stable post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774728 ↗MalfunctionSep 15, 2026Output Problem
It was reported that unstable rotation speed occurred. A 1.50mm Rotapro was selected for use. During procedure, it was noted that the rotation speed was unstable, it increased and decreased. The procedure was completed with a different device. There were no patient complications, and the patient condition was stable post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774392 ↗MalfunctionSep 15, 2026Output Problem
It was reported that unstable rotation speed occurred.A 1.50mm Rotapro was selected for use. During procedure, it was noted that the rotation speed was unstable, it increased and decreased. The procedure was completed with a different device. There were no patient complications, and the patient condition was stable post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774391 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
It was reported that the protective sleeve was fractured.A 1.50mm Rotapro was selected for use. During procedure, it was noted that the protective sleeve of the device was fractured. The procedure was completed with another of the same device. There were no patient complications, and patient condition was stable following the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773487 ↗MalfunctionSep 15, 2026Entrapment of Device
It was reported that the burr and wire became stuck.A 1.50mm Rotapro and a RotaWire Drive were selected for use. During the procedure, it was noted that the burr and wire became stuck. The Rotawire and burr were removed together from the patient as a single unit. The procedure was completed with another burr and another wire. There were no patient complications, and the patient was in good condition after the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773486 ↗MalfunctionSep 14, 2026Entrapment of Device; Noise, Audible; Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763518 ↗MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material; Output Problem; Noise, Audible; Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739334 ↗InjurySep 11, 2026Failure to Advance; Device Damaged by Another Device; Output Problem
It was reported that the wire detached and a perforation occurred requiring additional surgery.The 15mm long and 95% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery with a vessel diameter of 3.0 mm. A 1.25mm Rotapro and Rotawire Drive were selected for use. During the procedure, difficulty crossing the lesion was experienced. Seventeen ablations were performed at a set speed of 190,000 rpm for 15 seconds each. The physician noted reductions in speed ranging from 2,000 to 10,000 rpm during ablation. A perforation was observed on the opposite side of the calcified nodule and upon withdrawal of the devices it was noted that the RotaWire had separated a few centimeters proximal to the radiopaque marker. It was considered possible that the separation was due to burr contact. Bypass grafting of the proximal LAD was performed to treat the perforation. No device fragments were left inside the body. Following surgery, the patient was weaned from mechanical ventilation, resumed oral intake, and is currently undergoing rehabilitation.
Patient problems: Perforation
MAUDE report 50735305 ↗MalfunctionSep 10, 2026Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725099 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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