Single Use Aspiration Needle NA NA-401D-1521Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170196683), received between Jun 22, 2022 and Aug 15, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE ASPIRATION NEEDLE PIERCED THE METAL SHEATH. THE ISSUE OCCURRED DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817063 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEW THE FOLLOWING LITERATURE TITLED "VALUE OF DIFFERENT BRONCHOSCOPIC SAMPLING TECHNIQUES IN DIAGNOSIS OF SARCOIDOSIS: A PROSPECTIVE STUDY OF 151 PATIENTS". LITERATURE SUMMARY: THIS PROSPECTIVE STUDY DESCRIBES THE VALUE OF DIFFERENT BRONCHOSCOPIC SAMPLING TECHNIQUES IN DIAGNOSIS OF SARCOIDOSIS. OF THE 164 PATIENTS STUDIED, 151 WERE FINALLY DIAGNOSED AS SARCOIDOSIS. GRANULOMAS WERE DEMONSTRATED IN 127 (84.2%) PATIENTS. THE PROCEDURE WAS PERFORMED IN THE SUPINE POSITION BY TRANS NASAL (OR ORAL) ROUTE BY EXPERIENCED FACULTY OR BY FELLOWS UNDER DIRECT SUPERVISION, USING A FIBEROPTIC BRONCHOSCOPE (BF-1T20 OR BF-TE2; OLYMPUS, JAPAN; FB 19TV; PENTAX, JAPAN). EBB (AT LEAST 4 SPECIMENS) WAS PERFORMED WITH THE STANDARD BIOPSY FORCEPS (FB15C; OLYMPUS) FROM THE ABNORMAL LOOKING AREAS IF ANY; OR FROM SECONDARY CARINAL AREAS. TRANSBRONCHIAL LUNG BIOPSIES (AT LEAST 4 SPECIMENS) WERE OBTAINED WITHOUT FLUOROSCOPY USING THE STANDARD BIOPSY FORCEPS (FB19C; OLYMPUS) FROM THE SITE OF MAXIMAL INVOLVEMENT ON CT CHEST OR FROM RIGHT LOWER LOBE, IF CT CHEST WAS NORMAL. THREE PASSES WERE ATTEMPTED IN EACH LYMPH NODE STATION USING THE CONVENTIONAL 21 G TBNA NEEDLE (SMOOTH SHOT; OLYMPUS) WITHOUT AN

  Patient problems: Pneumothorax

  MAUDE report 15074969 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "CONVENTIONAL TRANSBRONCHIAL NEEDLE ASPIRATION VERSUS ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WITH OR WITHOUT RAPID ON-SITE EVALUATION, FOR THE DIAGNOSIS OF SARCOIDOSIS: A RANDOMIZED CONTROLLED TRIAL." LITERATURE SUMMARY: THIS STUDY DESCRIBES ABOUT CONVENTIONAL TRANSBRONCHIAL NEEDLE ASPIRATION VERSUS ENDOBRONCHIAL ULTRASOUND¿GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WITH OR WITHOUT RAPID ON-SITE EVALUATION, FOR THE DIAGNOSIS OF SARCOIDOSIS. EIGHTY PATIENTS WITH SUSPECTED SARCOIDOSIS WERE RANDOMIZED 1:1:1:1 INTO 4 GROUPS: C-TBNA WITH OUT ROSE (TBNA-NR), C-TBNA WITH ROSE (TBNA-R), EBUS-TBNA WITHOUT ROSE (EBUS NR), AND EBUS-TBNA WITH ROSE (EBUS-R). EBB AND TBLB WERE PERFORMED IN ALL PATIENTS. FLEXIBLE BRONCHOSCOPY WAS PERFORMED THROUGH THE NASAL/ORAL ROUTE USING THE OLYMPUS BF-TE2 FIBEROPTIC BRONCHOSCOPE/OLYMPUS 1T180 VIDEO BRONCHOSCOPE. C-TBNA WAS PERFORMED FROM THE SUBCARINAL (STATION 7) AND/OR LOWER RIGHT PARATRACHEAL (4R) STATIONS USING THE 21-G TBNA NEEDLE (SMOOTH SHOT NA-401D-1521; OLYMPUS). EBUS-TBNA WAS PERFORMED THROUGH THE ORAL ROUTE UNDER MODERATE SEDATION AFTER INSERTION OF A BITE BLOCK, USING THE E

  Patient problems: Pneumothorax

  MAUDE report 15053140 ↗
• MalfunctionJun 22, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PROCEDURE BEING PERFORMED WE AS A BRONCHOSCOPY. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PROCEDURE WAS COMPLETED WITH WASHINGS INSTEAD TO CONFIRM CANCER DIAGNOSIS. THE CUSTOMER HOPES THIS IS AS RELEVANT AS AN ASPIRATION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNSURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14772452 ↗