AART Pectoralis Implant BRecalls & reported problems
Aart · Pectoral Sty 2 Sz 3 L Sterile · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B4905002035B0), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
1 other recall cover devices cleared under the same FDA submission (K021337); they may or may not involve this specific model.
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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2022Patient-Device Incompatibility
PATIENT HAVING REOCCURRING SEROMAS REQUESTED REPLACEMENT IMPLANT. IMPLANT WAS REMOVED AND DESTROYED PRIOR TO CONTACTING US ABOUT COMPLAINT. ALL RELEVANT INFORMATION REGARDING COMPLAINT ACQUIRED FROM DOCTOR. ON (B)(6) 2019, PATIENT DEVELOPED SEROMA; (B)(6) 2019 PT RETURNED, IMPLANT ADJUSTED (B)(6) 2019. DRAIN PLACE FOR CONTINUED SEROMA (B)(6) 2019. IMPLANT REMOVED (B)(6) 2020 CONTACTED US FOR REPLACEMENT IMPLANT. PATIENT DEVELOPED SEROMA POST - OP. CONTINUED SEROMAS REQUIRED IMPLANT REMOVAL AND REPLACEMENT UNABLE TO EXAMINE OR PERFORM TESTING ON EXPLANTED PRODUCT. DOCTOR REMOVED AND DESTROYED PRIOR TO CONTACTING US FOR REPLACEMENT. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Seroma
MAUDE report 15562682 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021337. One submission often covers many models, so check the product and lot details in each record.
- Z-0948-2026 · Sep 26, 2025 · Open, ClassifiedBrand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pect
Other Implant, muscle, pectoralis devices
- Powerflex™ Pectoral Implant Size 4, RightImplantech Associates, Inc. · Implant, Muscle, Pectoralis2 reports
- Pectoralis Implant ACP 2-2Hanson Medical, Inc. · Implant, Muscle, Pectoralis1 report
- Powerflex™ Pectoral Implant, Novack Style 2, SDM Size: 1, Right SideImplantech Associates, Inc. · Implant, Muscle, Pectoralis1 report
- Powerflex™ Pectoral Implant, Novack Style 2, SDM Size: 1, Left SideImplantech Associates, Inc. · Implant, Muscle, Pectoralis1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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