ARROW IPN033793Recalls & reported problems
Teleflex Incorporated · OnControl® Bone Marrow Biopsy System Comprehensive Tray, 102mm · Class 2
Data updated Oct 13, 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 10816000012304), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K142377); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2023Material Separation; Material Separation
IT WAS REPORTED THAT: DURING A BIOPSY OF A RIGHT ILIAC CREST. THE PHYSICIAN USED THE SAME BMB TRAY ON TWO SEPARATE LESION SITES INSTEAD OF USING THE BLB TRAY, LESIONS WERE SCLEROTIC. PATIENT DID FINE BUT LOWER HALF OF NEEDLE LEFT IN PATIENTS' HIP. NO SURGERY REQUIRED, AND NO EXTENDED STAY WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 17601740 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142377. One submission often covers many models, so check the product and lot details in each record.
- Z-0678-2017 · Nov 8, 2016 · TerminatedOnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult a
- Z-0676-2017 · Nov 8, 2016 · TerminatedARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest o
- Z-0675-2017 · Nov 8, 2016 · TerminatedARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marro
- Z-0679-2017 · Nov 8, 2016 · TerminatedARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adul
Other Biopsy needle devices
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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